One of the biggest stumbling blocks for manufacturers, particularly those with legacy devices, is clinical evidence under IVDR. Carlos Galamba, former technical reviewer and current VP of Intelligence and Innovation at RQM+, discusses the challenges and opportunities of the more stringent evidence requirements facing diagnostics developers.
With only one month until the compliance deadline, many medical device companies still have much to prepare in order to meet the requirements.
Beyond simply allowing for broader yet more efficient searches, leveraging software to automate literature reviews can organize references, assign screeners, and review screening decisions. This saves time, reduces bottlenecks, and, most importantly, leads to a highly transparent, standardized, and repeatable process that supports continuous CER and PER submissions across a product portfolio and for the life of a device.
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Leveraging big data and clinical evidence is top of mind.
Payer organizations face a host of issues in the conversion to ICD-10.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.